drugset
drugset / Trial / NCT04623606

Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones

NCT04623606 ↗

Phase 1/2 Unknown 15 enrolled Christian Medical College, Vellore, India Karolinska Institutet · collabMinistry of Science and Technology, India · collabVinnova · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

An exploratory, open label, multiple dose, phase I/II trial (n=15) evaluating safety and efficacy of intravenous and intraosseous infusion of allogeneic expanded fetal mesenchymal stem cells (MSC) for the treatment of severe Osteogenesis Imperfecta (OI) compared with historical and untreated prospective controls.

Timeline

Start
2019-05-20
Primary completion
2021-11
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BOOST cells Cell therapy 3e+06 cells/kg Intravenous

Indications

osteogenesis imperfecta